Dr David E Cummings, Professor of Medicine from the University of Washington, Dr Shashank Shah, Director of Laparo Obeso Centre, and Director, Department of Laparoscopic and Bariatric Surgery at Ruby Hall Clinic, Pune and Dr Jayashree Todkar, the Consultant General and Laparoscopic Surgeon at Poona Hospital and Ruby Hall Clinic, Pune explains the co-relation between diabetes and obesity, how bariatric surgery can help and their research work on this topic, in conversation with Raelene Kambli
| Dr David E Cummings | Dr Jayashree Todkar | Dr Shashank Shah |
How is diabetes in India different, why is it a challenge and what could be done to tackle this situation in India? Why are Indians prone to diabetes?
Diabetes in India is different due to multiple reasons:
Higher body fat: Except for fat, all other components like bone mass density, etc., are less in Indians, as compared to Caucasians. Hence, though Indians appear thin, they actually have a high percentage of fat in their bodies. This is an Indian paradox and is known as ‘The Thin-Fat Indian’.
Indians have a higher percentage of fat in their bodies due to a thrifty genotype or thrifty gene hypothesis. Over the generations, Indians suffered from malnutrition or under nutrition and therefore, genetically their bodies were designed to store fat, in order to fight malnutrition. However, in the current scenario, this genetic makeup has evolved as obesity, in India.
High incidence of central obesity: Indian obesity is seen predominantly in the belly. For eg., for a BMI of 35, an American will appear overall large. However, an Indian at a BMI of 35 will have thin limbs but a prominent belly. Hence, they may not fall under the definition of obesity or morbid obesity. However, fat is the largest endocrine organ in the body and it secretes various hormones and peptides required for various body functions. Therefore, high concentration of fat in abdominal area can cause high blood pressure, cholesterol, heart disease, diabetes, etc. Hence, abdominal obesity makes Indians more susceptible to diseases like diabetes and CVDs, etc., as compared to Caucasians, who have overall obesity.
Hence, higher body fat percentage due to thrifty gene hypothesis and high incidence of central obesity make Indians genetically predisposed to developing Type 2 diabetes. Due to these genetic reasons, Indians also experience the onset of cardiovascular diseases, atleast 10 years earlier and at a lesser BMI, as compared to other ethnicities in the world. Therefore, India has become the diabetes capital of the world.
According to current guidelines, at what BMI levels does a patient qualify for a bariatric surgery?
The standard consensus by the National Institute of Health, US, permits bariatric surgery for any person with BMI of >40, without any comorbidities, or any person with BMI >35 along with any one uncontrolled co-morbidity. The new Asian guidelines, published in the Journal of Association of Physicians India, has lowered these levels for Indians, to BMI level of >37.5 without comorbidities, or to BMI of >32.5 with any one uncontrolled co-morbidity. Dr Shashank Shah was a core faculty member of this committee, which proposed the new Asian guidelines in 2009.
Why was there a need to look for alternate treatment options for treating Type II diabetes?
A large number of diabetics in India die of kidney failure, wounds, heart transplant, amputations, etc., every year. Available pharmacological treatments are neither able to control the progression of type II diabetes nor are they able to prevent the complications caused by the disease. If one looks at the current Indian studies, the best medical care is being offered to the patients and yet most of them suffer from uncontrolled diabetes. Over the period of time, uncontrolled diabetes ultimately results in increased cardiovascular risk as well.
Tell us more about the Roux-en-Y-Gastric Bypass (RYGB) surgery?
During RYGB, a small pouch is created in the upper part of the stomach, separating it from the rest of the stomach. This restricts the intake of food as the person tends to feel less hungry. Secondly, a small part of small intestine, the duodenum, is bypassed, by connecting the smaller, upper part of the stomach directly with lower part of the small intestine. Since duodenum is a part of the small intestine that is responsible for absorption of calories and nutrients in the body, this surgery leads to weight loss in obese patients, post RYGB surgery.
However, it must be noted that the larger part of intestine is intact to absorb nutrients and there is no evidence of malabsorption in the patients who have undergone this procedure. RYGB has shown to result in complete remission or better management of type II diabetes. Hence, clinicians believe that this surgery induces hormonal changes in the body and is not merely a weight-loss surgery, but can also be a possible treatment for type II diabetes.
How does RYGB lead to better management of Type II diabetes?
Initially, it was thought that the small stomach size was responsible for weight loss in patients opting for RYGB surgery. Since the stomach size decreased after the procedure, it was believed that the patient would eat less frequently and hence, lose weight. Hence, bariatric surgery was initially thought to be a weight loss surgery only. However, in more recent times, it is being understood that RYGB is a metabolic surgery, which changes a person’s hunger and satiety pattern, thereby affecting the glucose production and absorption in the body.
Can you tell us more about the Comparison of Surgery vs Medicine for Indian Diabetes (COSMID) study on which you are working together?
COSMID study is being conducted in Pune. When it gets completed, it will serve as the Level 1 evidence for comparison of surgery vs medicine in management of Type II diabetes and will furnish details for any scientific body to for new guidelines for Type II diabetes treatment. A randomised controlled trial (RCT) is the highest level of evidence for all medical investigations, as the investigating surgeons do not decide the course for treatment for the selected patients, in this case, choice of treatment through RYGB surgery or medication.
Till date, only three RCTs have been conducted across the globe to compare the results of surgery vs. pharmacological treatment for management of Type II diabetes. These trials have been conducted in US, Italy and Australia. COSMID is the fourth such trial, being the first and the only one of its kind in entire Asia. The results of the third and most recent trial, termed as Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently (STAMPEDE) Study, were published in The New England Journal of Medicine in March 2012.
Who would be funding this research in India?
US Metabolic Council and Worldwide Metabolic Council will be funding this research in India.
What about the guidelines for conducting clinical trials in India?
In India, the guidelines for clinical trials are laid down by the Indian Council of Medical Research (ICMR) and Independent Review Board (IRB)/Ethics Review Committee. COSMID has been passed by ICMR and ethics committee, and is registered under the WHO.
How long will this study take?
The study results will be out in the next two to three years’ time.
Are there any side-effects of the surgery or do the patients have to take any precautions?
There are guidelines for patients in terms of diet, etc., which they are able to follow much better after surgery. Because there is rerouting of intestines, there can be deficiency of Vitamin B12, iron, calcium, and other minerals, due to malabsorption in the body. However, all of this can be consumed in the form of multivitamin pills or tablets, which the patients don’t find a major challenge. Minor nutritional supplements for lifetime are preferred options by diabetics, as compared to consuming supplements plus anti-diabetic, cholesterol-lowering medicines and insulin for the rest of their lives.
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Case study: Impact of RYGB surgery in managing diabetes |
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This study was done to find the impact of Roux-en-Y Gastric Bypass surgery in managing Type II diabetes in patients. It is a pilot study, a prospective study of RYGB for Type II diabetes mellitus in Asian Indians With BMI of < 35 kg/m2 The sample size of the stydy was 15 patients, not graded morbidly obese, suffering from Type II diabetes. The patient profile was as follows:
All patients underwent RYGB. The results were phenomenal. In the first month, average blood sugar level of all patients was about 100 and by nine months it was 89, which is completely normal. In the first month itself, 80 per cent of the patients were off all diabetic medication, by thethird month and thereafter, all of them were off diabetes medicine. As per the data on these patients after three to four years, most of the patients are still non-diabetic or minor diabetic.This was a small study but the results were extremely compelling. Hence, Dr Cummings and Dr Shah submitted the results of this study to get the grant for a top quality randomised controlled trial, to study the full balance of risks and benefits of surgery vs medical and behavioural therapy in diabetes patients who have a BMI of 25-35 and would not qualify for surgery by body weight but have a need for alternate treatment to treat their Type II diabetes. This RCT, which is currently underway has been named as Comparison Of Surgery vs Medicine in Indian Diabetes (COSMID)
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How critical is this study in the Indian context? Would these study results be applicable to Indians across the globe?
In order to apply findings of STAMPEDE, the third RCT conducted in America, to Indians, we need to study the efficacy of surgery vs medicines as a treatment option for Type II diabetes in Indians. This is because, typically, people of Indian ethnicity have a different set of genes, body composition, distribution of fat and genes that make the cells, which produce insulin, relatively poor.
There are downsides and risks to the surgery as well. Hence, in a randomised trial , one has to be very ethical and follow all rules and regulations. However, it is a relatively safe surgery. The chances of mortality within 30 days of surgery is 0.2 per cent, while for gall bladder surgery, which is the most common operation, chances of dying are 0.3 per cent.
Yes, these study results will be applicable to Indians in the entire world. Although environmental changes have an impact on the human body, genetic make-up remains the same and plays a larger role in people acquiring such diseases.